Second-Generation TAVR Device Overcomes Issues of Current Valves

San Francisco, CA—New data from the REPRISE II trial indicate that the Lotus Valve System was associated with low rates of complications in patients with severe symptomatic aortic stenosis at high surgical risk.

The Lotus Valve System is a completely repositionable and retrievable valve composed of bovine pericardium and a woven nitinol frame. It is deployed using a preloaded system around a central radiopaque marker to aid precise positioning. It has a locking mechanism and an adaptive seal designed to conform to irregular anatomic surfaces and minimize paravalvular leaks.

Researchers prospectively enrolled 120 patients at 14 international sites from October 2012 to April 2013. After 30 days, follow-up data were available on an intention-to-treat basis in 99.2% of patients (n=119). Slightly more than half of patients were women (56.7%), the average age was 84.4 years and 75.8% were classified as NYHA class III or IV.

Successful implantation and positioning of the valve (Boston Scientific) was achieved in all patients. The study met its primary device performance endpoint of mean aortic valve pressure gradient at 30 days compared with a performance goal of 18 mm Hg (see Figure). The primary safety endpoint, all-cause mortality at 30 days, was 4.2%. Rate of disabling stroke at 30 days was also low (1.7%), Ian T. Meredith, MBBS, PhD, of Monash Medical Centre, Australia, reported at TCT 2013.

 Aortic regurgitation at 30 days was negligible in 99% of patients (78.4% none, 5.2% trace and 15.5% mild). The rate of newly implanted pacemakers was 28.6%, and was due to overstretching of the left ventricular outflow tract in 55.9% of patients. NYHA class scores also improved, with only 8% of patients classified as class III and 0.9% as class IV at 30 days. 

Additional clinical event rates were comparable to what has been reported for other valves, Meredith said.

“Results suggest the differentiated second-generation Lotus TAVR device will be a valuable addition for treatment of severe aortic stenosis,” he said. Future studies are planned to randomize patients to this device against the Sapien valves (Edwards Lifesciences).

In an online discussion, digital moderator Davide Capodanno, MD, PhD, of Ferrarotto Hospital, Italy, said this device is “another new player in the field,” although direct valve comparisons are needed and the pacemaker implantation rate is “quite high.”

Meredith said the need for pacemaker implantation could be significantly lower if additional sizes of the valve were available. The study used 23-mm and 27-mm manually expandable devices.

The panel discussion also focused on the stroke rate. Meredith said the device is “in the ballpark [of other studies]” with regard to major stroke; however, “for minor stroke rate, we are a little higher [4.2%]. But I firmly believe that is due to the fact that we had pre- and post-neurological assessments.”

The REPRISE study was funded by Boston Scientific.

Capodanno reports receiving consultant fees/honoraria from Daiichi-Sankyo/Eli Lilly and The Medicines Company.

Meredith reports receiving consultant fees/honoraria from Boston Scientific and Medtronic and serving as a proctor for Boston Scientific.